The Efficacy of Regional Scalp Block in Craniotomy

Universitas Airlangga

Status and phase: Completed; Early Phase 1

Conditions: Craniotomy Surgery; Scalp Nerve Block

Treatments: Procedure: nerve block with 0.5% ropivacaine; Drug: General anesthesia and opioids (fentanyl, propofol, rocuronium)

Study type: Interventional

Funder types: Other

Identifiers

NCT06720285

IRB: 0769/KEPK/IX/2023

INA-XOYLZRE (Registry Identifier)

Details and patient eligibility

About

The objective of this clinical trial is to evaluate the role of scalp nerve block in craniotomy. The primary questions it seeks to answer are: What are the efficacy and safety profiles of scalp nerve block in craniotomy? The anesthesia protocol and monitoring were standardized for all participants. Participants were divided into two groups: the scalp nerve block group and the general anesthesia group. General anesthesia was induced using fentanyl (1-2 mcg/kg), propofol (1-2 mg/kg), and rocuronium (0.6 mg/kg). In the scalp nerve block group, a nerve block was administered using 0.5% ropivacaine.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged >18 years
• American Society of Anesthesiologists (ASA) classification I-III
• Glasgow Coma Scale (GCS) score ≥ 13
• Elective craniotomy

Exclusion criteria

• Patients with cardiovascular abnormalities, impaired renal and hepatic function, diabetes mellitus, systemic and/or scalp local infection, and those with a history of current dexamethasone administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Standard Treatment with Scalp Nerve Block

Experimental group

Description:

General anesthesia induction was performed by administering fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Subsequently, scalp nerve block was performed with 0.5% ropivacaine. During surgery, a sudden rise of heart rate and blood pressure higher than 20% from baseline was considered as pain, and a bolus of fentanyl was administered as rescue analgesia.

Treatment:

Drug: General anesthesia and opioids (fentanyl, propofol, rocuronium)

Procedure: nerve block with 0.5% ropivacaine

Standard Treatment

Active Comparator group

Description:

General anesthesia induction was performed by administering fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Then, continuous fentanyl infusion as analgesia maintenance as the standard treatment. During surgery, a sudden rise of heart rate and blood pressure higher than 20% from baseline was considered as pain, and a bolus of fentanyl was administered as rescue analgesia.

Treatment:

Drug: General anesthesia and opioids (fentanyl, propofol, rocuronium)